Inspections, Compliance, Enforcement, and Criminal Investigations
Lactroport USA 01-Nov-02
Food and Drug Administration
240 Hennepin Avenue
Minneapolis, MN 55401-1966
November 1, 2002
RETURN RECEIPT REQUESTED
Refer to MIN 03 - 04
Gerhard H. Simon
2819 Highway F South
Blue Mounds, Wisconsin 53517
Dear Mr. Simon:
An inspection of your facility was conducted on June 27,
July 1, and July 3, 2002.
contained in Title 21, Code of Federal Regulations, Part
133 (21 CFR 133).
made by the investigators show your products to be misbranded
Pasteurized process cheese is subject to the standard of
identity found in 21 CFR 133.169. The optional dairy ingredients that may
be used in pasteurized process cheese are specified in 133.169(d)(2) as ?[c]ream,
anhydrous milkfat, dehydrated cream, or any combination of two or more of
these, in such quantity that the weight of the fat derived therefrom is less
than 5 percent of the weight of the pasteurized process cheese.? Milk
Pasteurized process cheese food containing fruits, vegetables,
or meats is subject to the standard of identity found in 21 CFR 133.174. According
to 133.174(a), pasteurized process cheese food containing fruits, vegetables,
or meats is further subject to the requirements of 133.173, with specified
exceptions. The optional dairy ingredients permitted in 133.173(d) are ?.
. .cream, milk, skim milk, buttermilk, cheese whey, any of the foregoing from
which part of the water has been removed, anhydrous milkfat,
Pasteurized process cheese spread with fruits, vegetables, or meats is subject to the standard of identity found in 21 CFR 133.180. According to 133.180(a), pasteurized process cheese spread with fruits, vegetables, or meats is further subject to the requirements of 133.179, with certain exceptions. The optional dairy ingredients permitted in 133.179(d) are ?...cream, milk, skim milk, buttermilk, cheese whey, any of the foregoing from which part of the water has been removed, anhydrous milkfat,
dehydrated cream, albumin from cheese whey, and skim milk cheese for manufacturing.? Milk Protein Concentrate is not listed as an optional dairy ingredient in 133.179(d) and is not listed as an exception in 133.180(a). However, according to the Work Order for -brand Pasteurized Process Cheese Spread with Jalapenos, 36 pieces/case, 12 ounces/piece, this product includes Milk Protein Concentrate.
The use of Milk Protein Concentrate in these products constitutes a violation of Section 403(g)(1) of the Act because the products are represented as foods for which standards of identity have been prescribed by regulation and the use of Milk Protein Concentrate in these products does not conform to the standards.
We request that you notify this office in writing within 15 working days of receipt of this letter stating the actions you will take to correct the violations and to prevent their recurrence. If corrective action cannot be completed within 15 working days, state the reason for the delay and a reasonable time within which the corrections will be completed.
Failure to make prompt corrections may result in further enforcement action, including seizure and injunction, being initiated by the Food and Drug Administration (FDA).
This letter does not represent a comprehensive review of all of the products distributed by your firm, nor does it represent a complete review of all product labeling. As president, it is your responsibility to ensure that all products distributed by your firm are in compliance with the Act and its implementing regulations.
Your reply should be directed to Compliance Officer Tyra S. Wisecup at the addressindicated in the letterhead. Ms. Wisecup may be reached at (612) 334-4100 ext. 124.